June 24, 2026

• FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer
• FDA Approves First Treatment Shown to Reduce the Risk of Acute Pancreatitis in Adults with Severe Hypertriglyceridemia
• FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer
• Public Notification: PRE-FORMANCE BLACK may be harmful due to hidden ingredient

June 22, 2026

• Draft Guidance: Master Protocols for Drug and Biological Product Development
• Draft Guidance: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
• Draft Guidance: Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.